Nobilis Influenza H5N6


adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Nobilis Influenza H5N6 has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 26/07/2010

Authorisation details

Product details
Nobilis Influenza H5N6
Agency product number
Active substance
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Anatomical therapeutic chemical veterinary (ATCvet) codes
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Intervet International BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

05/07/2010 Nobilis Influenza H5N6 - EMEA/V/C/000125 - S/0001

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For active immunisation of chickens against avian influenza type A, subtype H5.
Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.

Assessment history

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